Bacillus Thuringiensis Cry1B.34 Protein; Exemption From the Requirement of a Tolerance

<RULE> ENVIRONMENTAL PROTECTION AGENCY <CFR>40 CFR Part 174</CFR> <DEPDOC>[EPA-HQ-OPP-2022-0988; FRL-12514-01-OCSPP]</DEPDOC> <SUBJECT>Bacillus Thuringiensis Cry1B.34 Protein; Exemption From the Requirement of a Tolerance</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Environmental Protection Agency (EPA). <HD SOURCE="HED">ACTION:</HD> Final rule. <SUM> <HD SOURCE="HED">SUMMARY:</HD> This regulation establishes an exemption from the requirement of a tolerance for residues of the <E T="03">Bacillus thuringienisis</E> Cry1B.34 protein (hereafter Cry1B.34 protein) in or on the food and feed commodities of corn, field; corn, sweet; and corn, pop when used as a Plant-Incorporated Protectant (PIP). Pioneer Hi-Bred International, Inc. submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of Cry1B.34 protein. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> This regulation is effective February 25, 2025. Objections and requests for hearings must be received on or before April 28, 2025, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the <E T="02">SUPPLEMENTARY INFORMATION</E> ). </EFFDATE> <HD SOURCE="HED">ADDRESSES:</HD> The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2022-0988, is available online at <E T="03">https://www.regulations.gov.</E> Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at <E T="03">https://www.epa.gov/dockets.</E> <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Madison Le, Biopesticides and Pollution Prevention Division (7511P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone number: (202) 566-1400; email address: <E T="03">BPPDFRNotices@epa.gov.</E> </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">I. General Information</HD> <HD SOURCE="HD2">A. Does this action apply to me?</HD> You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include: • Crop production (NAICS code 111). • Animal production (NAICS code 112). • Food manufacturing (NAICS code 311). • Pesticide manufacturing (NAICS code 32532). If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under <E T="02">FOR FURTHER INFORMATION CONTACT</E> . <HD SOURCE="HD2">B. How can I get electronic access to other related information?</HD> You may access a frequently updated electronic version of 40 CFR part 174 through the Office of the Federal Register's e-CFR site at <E T="03">https://www.ecfr.gov/current/title-40.</E> <HD SOURCE="HD2">C. How can I file an objection or hearing request?</HD> Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. If you fail to file an objection to the final rule within the time period specified in the final rule, you will have waived the right to raise any issues resolved in the final rule. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2022-0988, in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing and must be received by the Hearing Clerk on or before April 28, 2025. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b). The EPA's Office of Administrative Law Judges (OALJ), in which the Hearing Clerk is housed, urges parties to file and serve documents by electronic means only, notwithstanding any other particular requirements set forth in other procedural rules governing those proceedings. <E T="03">See</E> “Revised Order Urging Electronic Filing and Service,” dated June 22, 2023, which can be found at <E T="03">https://www.epa.gov/system/files/documents/2023-06/2023-06-22%20-%20revised%20order%20urging%20electronic%20filing%20and%20service.pdf.</E> Although the EPA's regulations require submission via U.S. Mail or hand delivery, the EPA intends to treat submissions filed via electronic means as properly filed submissions; therefore, the EPA believes the preference for submission via electronic means will not be prejudicial. When submitting documents to the OALJ electronically, a person should utilize the OALJ e-filing system at <E T="03">https://yosemite.epa.gov/oa/eab/eab-alj_upload.nsf.</E> <HD SOURCE="HD1">II. Background and Statutory Findings</HD> In the <E T="04">Federal Register</E> of February 23, 2023 (88 FR 11401 (FRL-10579-01-OCSPP)), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition by Pioneer Hi-Bred International, Inc., requesting that 40 CFR part 174 be amended by establishing an exemption from the requirement of a tolerance for residues of <E T="03">Bacillus thuringiensis</E> Cry1B.34 protein in maize. That document incorrectly noted the petition number as PP 2F29001 and the address of Pioneer as 8325 NW 62nd Avenue, Johnston, IA 50131. The correct petition number is PP 2F9001, and the correct address is 7100 NW 62nd Avenue, P.O. Box 1000, Johnston, Iowa 50131. That document referenced a summary of the petition prepared by the petitioner Pioneer Hi-Bred International, Inc., which is available in the docket, <E T="03">https://www.regulations.gov.</E> One comment was received on the notice of filing. EPA's response to this comment is discussed in Unit III.C. <HD SOURCE="HD1">III. Final Rule</HD> <HD SOURCE="HD2">A. EPA's Safety Determination</HD> Section 408(c)(2)(A)(i) of the FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is “safe.” Section 408(c)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings but does not include occupational exposure. Pursuant to FFDCA section 408(c)(2)(B), in establishing or maintaining in effect an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in FFDCA section 408(b)(2)(C), which require EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue . . . .” Additionally, FFDCA section 408(b)(2)(D) requires that the Agency consider, among other things, “available information concerning the cumulative effects of a particular pesticide's residues” and “other substances that have a common mechanism of toxicity.” EPA evaluated the available toxicity and exposure data on Cry1B.34 protein and considered its validity, completeness, and reliability, as well as the relationship of this information to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. A summary of the data upon which EPA relied and its risk assessment based on those data can be found within the document entitled “Product Characterization Review and Human Health Risk Assessment of the Insecticidal Plant-Incorporated Protectant Active Ingredient, Cry1B.34, and the Genetic Material Necessary (PHP79620) for its Production in Event DP910521 maize (OECD Unique Identifier: DP-91Ø521-2), and in Support of a Permanent Tolerance Exemption for Residues of this Protein when used as a Plant-incorporated Protectant in Corn” (hereafter Human Health Risk Assessment). This document, as well as other relevant information, is available in the docket for this action EPA-HQ-OPP-2022-0988. Cry1B.34 is a modified protein derived from the bacterium <E T="03">Bacillus thuringiensis</E> (Bt) and, when expressed in corn plants, provides protection against feeding damage caused by certain susceptible lepidopteran insect pests. Cry1B.34 is a chimeric protein comprising sequences from the Bt <E T="03">cry</E> 1B-class, <E T="03">cry</E> 1Ca1, and <E T="03">cry</E> 9Db1 genes. The Agency used a “weight of evidence” approach and determined that, Cry1B.34 protein represents a negligible risk to humans that consume Cry1B.34 maize products. Although there may be dietary exposure to residues of Cry1B.34 protein, such exposure presents no concern for adverse effects. Submitted data showed that no adverse toxic effects were observed in acute oral toxicity studies conducted with Cry1B.34 protein in mice. Additionally, a bioinformatics analysis found that Cry1B.34 protein does not exhibit homology to any known mammalian toxins. Likewise, the potential for allergenicity is low because: (1) the Cry1B.34 protein is a novel protein that was derived ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 20k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━